Bioanalytical Services
Let our experts solve your problems
With our unparalleled expertise and customized solutions, we can help you elevate your drug development process to the next level. Whether you need bioanalysis or pharmacokinetic analysis, we have the right team and the right tools. Don’t settle for less, choose Royalmount Laboratories as your partner for your drug development programs.
Small Molecule Bioanalysis
- Method development from first principles
- Transfer Sponsors’ methods directly
- Modification of Sponsor/ literature methods
- Full validation
- Partial / cross-validation
- ICH M10, EMA and FDA validation guidelines
- Selectivity, accuracy and precision, recovery and the various stability evaluations
- Hemolysis effect, lipemic effect, metabolite interference
Large Molecule Bioanalysis
- ELISA
- MSD
- Biomarkers (multiplex using MSD, Luminex, etc)
- Immunogenicity
- Hybridization-ELISA
- qPCR (DNA, RNA)
Platforms
- 2 x API 6500+ QTRAP
- 2 x API 6500+
- 8 x API 5000
- 2 x ICP-MS
- 2 x Multimode spectrophotometer readers
- 1 x Luminex
- 1 x QuantStudio 7 Pro
- 1 x Meso Sector S 600MM (MSD)
- 2 x Hamilton Star Robots
- Watson LIMS
- Antibody drug conjugates
- Alveolar macrophages
- Bi-specific antibodies
- Co-administered drugs
- Dried Blood Spot (DBS)
- Endogenous compounds
- Fusion proteins
- Large molecules
- Mabs
- Metabolites
- Microsampling
- Parent compounds
- Peptides
- Protein bind
- Proteins
- Recombinant proteins
- Small molecules
- Alveolar macrophage cells
- Aorta
- Bone marrow
- Brain
- Bronchoalveolar fluid (BALF)
- Cerebrospinal fluid (CSF)
- Eye tissues
- Heart
- Kidney
- Liver
- Lung
- Plasma
- Serum
- Skin
- Spleen
- Whole blood
We offer the best-in-industry lead-in times for method development, validation and sample analysis, and as needed, expedited QC’d/QA’d data and reports.
- Number of years in operation: >40
- Number of staff: >60
- Number of R&D scientists: 6
- Number of PK Scientists: 4
- Number of LC-MS/MS: 12
- Number of robotic liquid handlers: 2
- Number of -70C / -20C / refrigerated storage units: 10
- Number of samples analyzed each year: 450,000
- Number of methods developed and validated each month: 8
- Number of molecules analyzed: >450
- Number of non-proprietary validated methods: >500
- Number of different types of matrices analyzed: 17
- Bioanalytical run acceptance rate: >98.5%
- On-time delivery: >99%
- Incurred sample reanalysis failure rate: 0%
- Number of regulatory audits: 10
- Number of FDA 483s: 0
All types of bioanalytical samples (blood products and tissues) can be easily shipped to our facilities in Canada using most commercial couriers, and Royalmount Laboratories’ experienced team can handle customs clearance for you. From the US, it typically takes less than 48 hours for us to receive samples.
For NHP-related samples, our import permit is renewed annually to ensure that these can be readily shipped to us once the CITES permit is obtained by the exporting testing facility.
As needed, we can provide additional information on the correct procedures for shipping samples from any country to ensure timely and reliable delivery.
Royalmount Laboratories are licenced to conduct testing on Controlled Substances.
Having one of the largest regulated vaults for controlled products in Canada, including Scheduled Drugs, we can readily apply for your innovator Schedule I to IV or controlled products to be added to our extensive, multi-page controlled product license. We maintain an active narcotics license and implement all necessary security measures to ensure the safety of your products and our staff.
- Responsiveness – reply to all messages within 1 business day
- Openness – complete transparency
- Teamwork – partnerships with Sponsors
- Flexibility – accommodate any special requests
- Communication – regular status updates
